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Last updated on May 28, 2012 at 18:09 EDT

Women’s Health Study Ending

February 22, 2005
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FORT LAUDERDALE, Fla. – Before the Women’s Health Initiative, the largest health study conducted in this country, most medical investigations involved only men.

“Maybe they thought we were all the same,” said Joanne Dinga, 68, of West Palm Beach, Fla. “Ain’t true.”

Dinga was one of 161,000 female volunteers in the 12-year, $725 million project that forever changed the medical establishment’s treatment of women. The findings of the initiative’s researchers, who are in the final stages of their work, were a surprise to the women, doctors and the researchers.

Before the study, when women reached a certain age they routinely got prescriptions for hormones from their doctors, who told them it would be good for them. The prevailing theory was that replacing the hormones lost at menopause would prevent heart disease and other vagaries of aging.

As the women go for their final clinical visits as the study winds down, they know they helped to prove that theory wrong.

The studies showed that taking hormone-replacement therapy after menopause increased – rather than decreased – the risk of heart disease by 81 percent in the first year.

The hormones also increased the risk of stroke, blood clots, invasive breast cancer and dementia. They helped women stave off bone loss and colorectal cancer, but researchers say the bad effects outweigh the good, and they do not recommend that women take the hormones long-term. Women who suffer hot flashes and night sweats severe enough to disrupt their daily living might still want to take hormone replacement on a short-term basis.

Results from two other arms of the studies – one on possible benefits of a low-fat diet, and another on whether vitamin D and calcium will prevent bone loss – are being analyzed and will be published in October. The hormone studies were published in major journals JAMA and the New England Journal of Medicine in 2002, 2003 and 2004.

Dr. Mary Jo O’Sullivan, who led the South Florida arm of the study at the University of Miami’s Miller School of Medicine, said she and other doctors thought hormone replacement was a good idea.

“It made perfect sense because women have less cardiovascular disease than men until 10 years after menopause, so it appeared that hormones were being protective,” O’Sullivan said. “It was all thought to be estrogen-progesterone-related.”

Dinga, who volunteered for the low-fat diet arm of the trial, said she didn’t want to be in the hormone trial because of an earlier experience with the pills.

“My doctor had insisted that I be on it, but I didn’t feel good when I was taking it and I quit,” Dinga said. “Now I feel vindicated.”